Acero Crowns ES

GUDID 00810120870656

Park - Istre, LLC

Preformed dental crown, temporary
Primary Device ID00810120870656
NIH Device Record Keyab0b7057-edd6-4d50-861b-031b7b3d6466
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcero Crowns ES
Version Model NumberES F6
Company DUNS006672536
Company NamePark - Istre, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810120870656 [Primary]

FDA Product Code

ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-30

On-Brand Devices [Acero Crowns ES]

00810120870779ES U6
00810120870762ES U5
00810120870755ES U4
00810120870748ES U3
00810120870731ES U2
00810120870724ES U1
00810120870717ES G6
00810120870700ES G5
00810120870694ES G4
00810120870687ES G3
00810120870670ES G2
00810120870663ES G1
00810120870656ES F6
00810120870649ES F5
00810120870632ES F4
00810120870625ES F3
00810120870618ES F2
00810120870601ES F1
00810120870595ES E6
00810120870588ES E5
00810120870571ES E4
00810120870564ES E3
00810120870557ES E2
00810120870540ES E1
00810120870533ES D6
00810120870526ES D5
00810120870519ES D4
00810120870502ES D3
00810120870496ES D2
00810120870489ES D1

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